CE Takaddama ta MDD

EC Takaddun shaida

Cikakken Tsarin Tabbatar da Inganci

Takaddun shaida.: A'a. Aiki.

10000322014-PA-NA-IND PRJC-581415-2018-PRC-IND

Wannan don tabbatar da cewa tsarin inganci na:

27 May 2024

Kamfanin Tekna Manufacturing Private Limited

C19, Masana'antu, Guindy, Chennai - 600 032, India.
Don ƙira, samarwa da bincika samfuran ƙarshe / gwajin:

'YAN CIKIN HYPERBARIC

An kimanta game da:

AN BAYYANA HANYAR MAGANAR GASKIYA GASKIYA A CIKIN ANNEX II BAYANAN SASHE NA 4 NA MAJALISAR DIRECTIVE 93/42 / EEC AKAN NA'URORUN MAGUNGUNA, KAMAR YADDA AKA YI

kuma ya sami biyan bukata.

Detailsarin bayani game da samfurin (s) da sharuɗɗan satifiket ana ba su fiye da kima.

Wuri da kwanan wata:

Høvik, 08 Yuli 2020

for:

DNV GL PRESAFE AS Sanarwar Jiki Babu.: 2460

______________________________________________________________________________

Mariann Jeremiassen

Takaddun shaida an tabbatar dashi ta hanyar fasaha ta hanyar fasahar toshewa. Don ƙarin bayani, duba www.dnvgl.com/assurance/certificates-in-the- blockchain.html

Farashin 021

Sanarwa: Takaddun shaida yana ƙarƙashin sharuɗɗa da halaye kamar yadda aka bayyana a Yarjejeniyar Takaddun shaida. Rashin yin biyayya zai iya sa wannan Takaddun ba shi da inganci.

JIKIN SANARWA: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Kamfanin Rijista Babu: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Shafin 1 na 3

Takaddun shaida.: A'a. Aiki.

10000322014-PA-NA-IND PRJC-581415-2018-PRC-IND

Hakoki

27 May 2020

Aikace-aikacen Umurnin Majalisar 93/42 / EEC na 14 ga Yuni 1993, wanda aka ɗauka azaman “Forskrift om Medisinsk Utstyr” daga Ma’aikatar Kiwon Lafiya da Kulawa ta Norway.

Tarihin satifiket:

Bayanin Bita

0.0 Asali na Asali na Asali wanda wannan Takaddun shaida ta rufe:

Ranar bayarwa

2020-07-08

Class

IIb

Samfur Description

Rukunin Hyperbaric Ɗauki

Musanya Hymbers na Hyperbaric

Ctungiyoyin Hyperbaric na rectangular

Reungiyoyin Hyperbaric na Yanki na Zamani masu daidaito

Product Name

Monoplace Hyperbaric Chambers 32 "zuwa 40" Multipla Hyperbaric Chambers 60 "zuwa 96"

IIb Yankin Hyperbaric na Yanki 6 zuwa 10 kujeru IIb

Ctungiyoyin Hyperbaric na ctananan Yanki 2 zuwa kujeru 12

IIb

Tekna Manufacturing Private Limited C19, Masana'antun Masana'antu, Guindy, Chennai - 600 032, Indiya

Wakilin EU

OBELIS SA, Bd. Janar Wahis, 53 1030 Brussels, Belgium.

Ana shigar da cikakken jerin na'urorin tare da Sanarwar Jiki

Shafukan da wannan takardar shaidar ta rufe
Adireshin Sunan Yanar Gizo

JIKIN SANARWA: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Kamfanin Rijista Babu: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Shafin 2 na 3

Takaddun shaida.: A'a. Aiki.

10000322014-PA-NA-IND PRJC-581415-2018-PRC-IND

Sharuɗɗa da

27 May 2020

Takaddun shaida yana ƙarƙashin ka'idodi da halaye masu zuwa:

  • Duk wani furodusa (duba 2001/95 / EC don tabbataccen ma'ana) yana da alhakin lalacewa sakamakon lahani a cikin sa

    samfurin (s), daidai da umarnin 85/374 / EEC, kamar yadda aka gyara, game da abin da ya hau kan lahani

    kayayyakin.

  •  Takardar shaidar tana aiki ne kawai don samfuran da / ko wuraren samar da kayayyaki da aka jera a sama.

  • Maƙerin masana'antu zai cika alƙawari waɗanda suka samo asali daga tsarin inganci kamar yadda aka yarda da shi

    shi don haka ya kasance ya isa kuma ingantacce.

  • Maƙerin zai sanar da Presafe game da duk wani sabunta tsarin da aka yi niyyar sabuntawa kuma Presafe zai yi

    tantance canje-canje kuma yanke shawara idan takardar shaidar ta kasance mai inganci.

  • Will Za'a gudanar da bincike na lokaci-lokaci, don tabbatar da cewa Maƙeran yana kula da aiki da shi

    ingancin tsarin. Presafe yana da haƙƙi, a kan tabo ko bisa la'akari da zato, don kai ziyarar bazata.

    Mai zuwa na iya sanya wannan Takaddun ba daidai ba ne:  Canje-canje a cikin tsarin inganci mai shafar samarwa.
    Aud Ba a yin binciken kuɗi na lokaci-lokaci a cikin taga lokacin da aka yarda.

    Bayyanar da daidaito da alamar samfur

    Lokacin saduwa da sharuɗɗa da sharuɗɗan da ke sama, mai samarwa na iya zana sanarwar EC ta dacewa kuma ta sanya alamar CE ta hanyar doka ta hanyar lambar sanarwa ta Jikin sanarwa na Presafe.

    Karshen satifiket

JIKIN SANARWA: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Kamfanin Rijista Babu: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Shafin 3 na 3

Ana buƙatar taimako don zaɓar Ɗaukaka Mafi Tsarki?